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Travere Therapeutics Submits Supplemental New Drug Application to FDA for FILSPARI® for IgA Nephropathy

Monday, March 11, 2024

Travere Therapeutics, Inc. (Nasdaq: TVTX) has announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking full approval for FILSPARI® (sparsentan) in treating IgA nephropathy (IgAN). Previously granted accelerated approval in February 2023, FILSPARI was the first non-immunosuppressive treatment targeting glomerular injury in the kidney to reduce proteinuria in adults with primary IgAN at risk of rapid disease progression. The sNDA is based on 2-year confirmatory results from the Phase 3 PROTECT Study, which is the only head-to-head study in IgAN against an active comparator.

Eric Dube, Ph.D., president and CEO of Travere Therapeutics, highlighted the positive impact FILSPARI has had since its accelerated approval and emphasized the potential of gaining full approval to reach more individuals affected by IgAN. FILSPARI, administered once daily orally, directly targets glomerular injury by inhibiting two critical pathways of IgAN disease progression (endothelin-1 and angiotensin II). It is also the first non-immunosuppressive therapy approved for this rare kidney disease. The sNDA submission is backed by results from the Phase 3 PROTECT Study demonstrating long-term kidney function preservation and significant reduction in proteinuria compared to the active comparator.

The FDA has 60 days to determine the acceptance of the application for review. Travere Therapeutics anticipates receiving notice regarding the acceptance and review timeline in the second quarter of 2024. Additionally, the Company, along with its European commercial partner CSL Vifor, announced the recommendation for conditional marketing authorization (CMA) for sparsentan by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP). A decision from the European Commission is expected in the second quarter of 2024.

IgA nephropathy (IgAN), also known as Berger's disease, is a rare progressive kidney disease characterized by the buildup of immunoglobulin A (IgA) in the kidneys, leading to various symptoms including hematuria, proteinuria, and a progressive loss of kidney function. IgAN affects a significant number of individuals globally and is one of the leading causes of kidney failure.

The PROTECT Study, the largest interventional study in IgAN to date, demonstrated the efficacy and safety of sparsentan compared to an active comparator. It showed significant reduction in proteinuria and long-term kidney function preservation over a 2-year period.



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